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NCT Number: NCT02509871

Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2)

This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).

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Key information

Conditions

Hormonal Therapy Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • postmenopausal women
  • patients requiring hormonal treatment
  • WHO performance status 0-2
  • patients initially included in MetaCa (AU882) protocol
  • Affiliation to a social security scheme (or be the beneficiary of such a plan)
  • patients who signed the informed consent form

Exclusion criteria

  • patients witg relapse, with metastases or other cancer
  • concurrent treatment with a drug test, or participation in a clinical trial within < 30 days
  • patients carrying an electronic medical device (eg pacemaker)
  • patients who refused to sign the consent form

Treatment and study plan

Body composition measurement

Other

DXA, impedance

Primary outcomes

  1. Measure of body composition

    Time frame: After more than a year of hormonal therapy

    To obtain additional data to those of Metaca study (AU882) to assess changes in body composition (fat mass, lean body mass in Kg) in women with breast cancer and treated with adjuvant hormonal therapy following chemotherapy

Secondary outcomes

  1. Evaluation of the distribution of abdominal fat by measuring the waist and hip circumference

    Time frame: After more than a year of hormonal therapy

  2. Assessment of anxiety and depression scores measured by Questionnaire HAD

    Time frame: After more than a year of hormonal therapy

    Questionnaire HAD

  3. Evaluation of quality of life measured by Questionnaire (QLQ-C30)

    Time frame: After more than a year of hormonal therapy

    Questionnaire (QLQ-C30)

  4. Evaluation of the time sitting measured by Questionnaire IPAQ

    Time frame: After more than a year of hormonal therapy

    Questionnaire IPAQ

  5. Evaluate the change in body composition longitudinally from the data of the study Metaca

    Time frame: Between after 1 and 6 months after chemotherapy and after more than a year of hormonal therapy

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer

Acronym: MetaCa2

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2015
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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